FDA.reportPublic FDA data

Gabapentin

Product NDC
65162-103
11-digit product format
651620103
Labeler code
65162
Product ID
65162-103_0a962d55-bd53-462f-b9a0-0bbb6930c93e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA078428
Marketing category
ANDA
Marketing start
2009-11-24
Substance
GABAPENTIN
Active strength
400 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431, 310432

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-103-03Gabapentin30 in 1 BOTTLECAPSULE3036
65162-103-10Gabapentin100 in 1 BOTTLECAPSULE10036
65162-103-11Gabapentin1000 in 1 BOTTLECAPSULE100036
65162-103-50Gabapentin500 in 1 BOTTLECAPSULE50036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-103-10EA - Each65162-103c0ccdb63-1068-4ab5-9171-6b4afc7cfd7212014-07-02
65162-103-50EA - Each65162-10393204acc-21c4-4284-a994-3bd21de090ce12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]24
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]24
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-103GABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS LLC]35Current NDC, Legacy NDC, 4 package rows20250201_507bf6d0-e7a2-413d-9848-cd2445a1411d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN507bf6d0-e7a2-413d-9848-cd2445a1411d36
310431gabapentin 300 MG Oral CapsulePSN507bf6d0-e7a2-413d-9848-cd2445a1411d36
310432gabapentin 400 MG Oral CapsulePSN507bf6d0-e7a2-413d-9848-cd2445a1411d36
310430gabapentin 100 MG Oral CapsuleSCD507bf6d0-e7a2-413d-9848-cd2445a1411d36
310431gabapentin 300 MG Oral CapsuleSCD507bf6d0-e7a2-413d-9848-cd2445a1411d36
310432gabapentin 400 MG Oral CapsuleSCD507bf6d0-e7a2-413d-9848-cd2445a1411d36
310432gabapentin 400 MG Oral CapsulePSN477691f5-0591-4544-840a-ac590e1f25a110
310432gabapentin 400 MG Oral CapsuleSCD477691f5-0591-4544-840a-ac590e1f25a110
310432gabapentin 400 MG Oral CapsulePSN657349fb-41a9-4814-b4ac-4c5afbdde9477
310432gabapentin 400 MG Oral CapsuleSCD657349fb-41a9-4814-b4ac-4c5afbdde9477
310430gabapentin 100 MG Oral CapsulePSNdbedccfb-0e27-4119-93b9-241c039e045a1
310431gabapentin 300 MG Oral CapsulePSNdbedccfb-0e27-4119-93b9-241c039e045a1
310432gabapentin 400 MG Oral CapsulePSNdbedccfb-0e27-4119-93b9-241c039e045a1
310432gabapentin 400 MG Oral CapsulePSN26a63b71-a734-811b-e063-6394a90a6a451
310430gabapentin 100 MG Oral CapsuleSCDdbedccfb-0e27-4119-93b9-241c039e045a1
310431gabapentin 300 MG Oral CapsuleSCDdbedccfb-0e27-4119-93b9-241c039e045a1
310432gabapentin 400 MG Oral CapsuleSCD26a63b71-a734-811b-e063-6394a90a6a451
310432gabapentin 400 MG Oral CapsuleSCDdbedccfb-0e27-4119-93b9-241c039e045a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-103-036516201030330 CAPSULE in 1 BOTTLE (65162-103-03) 30 capsule2009-11-240000-00-00NoNoCurrent
65162-103-1065162010310100 CAPSULE in 1 BOTTLE (65162-103-10) 100 capsule2009-11-240000-00-00NoNoCurrent
65162-103-11651620103111000 CAPSULE in 1 BOTTLE (65162-103-11) 1000 capsule2009-11-240000-00-00NoNoCurrent
65162-103-5065162010350500 CAPSULE in 1 BOTTLE (65162-103-50) 500 capsule2009-11-240000-00-00NoNoCurrent